FDA-Drug2026-07-08Class IIPROCESSING DEFECT

BD ChloraPrep CLear skin antiseptic recalled for lack of sterility assurance

OTHERNationwide distributionDrugs

What this means

BD ChloraPrep CLear, a chlorhexidine-based skin antiseptic solution in single-use applicators, was distributed without proper sterilization. Unsterilized applicators intended for further processing were mistakenly sent to customers outside the intended distribution channel. This affects 18,000 units across multiple lot numbers distributed nationwide.

  • Check if you have ChloraPrep CLear applicators from the affected lots (4088933, 4177711, 4195438, 5051114, 5070540, 5106254, 5141607, or 5196494).
  • Do not use applicators from these lots for patient care or medical procedures.
  • Contact your supplier or BD customer service with lot numbers and quantities for instructions on return or replacement.
The agency's original wording
Hazard

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Intended for
All ages
Illnesses reported
None reported
Sold states
Distributed Nationwide in the USA
Affected count
18,000 units
Manufactured in
1550 Northwestern Dr, N/A, El Paso, TX, United States
Products
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31, bulk catalog number 930480NSB

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0651-2026

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